Clinical Research Manager - Shockwave Medical (Remote)

Johnson & Johnson; Santa Clara (CA); Remote; USD 115,000 - 198,000; Full time

Job summary

An established industry player is seeking a Clinical Research Manager to lead global clinical studies in a fully remote role. This position involves overseeing project management activities, vendor coordination, and ensuring compliance with clinical and regulatory standards. The ideal candidate will have significant experience in clinical research, strong leadership skills, and a thorough understanding of Good Clinical Practice. Join a dynamic team that is dedicated to innovative healthcare solutions and make a profound impact on health for humanity. This role offers a unique opportunity to contribute to groundbreaking medical advancements while working from the comfort of your home.

Qualifications

• 10+ years experience in clinical research or relevant medical/scientific area.
• Strong knowledge of GCP, FDA, ISO regulations required.

Responsibilities

• Manage global clinical studies ensuring compliance with regulations.
• Oversee clinical trial budgets, vendor management, and data evaluation.

Skills

Clinical Research Management

Project Management

Good Clinical Practice (GCP)

Data Analysis

Communication Skills

Education

Bachelor’s Degree in a scientific field

Tools

EDC Data Management Systems

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com.

Job Function: R&D Operations

Job Sub Function: Clinical Trial Project Management

Job Category: Professional

All Job Posting Locations: Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Clinical Research Manager - Shockwave Medical (Remote) to join our team. The position is FULLY REMOTE and can sit anywhere in the US.

Position Overview:

The Clinical Research Manager is responsible for the day-to-day management of a global clinical study. The Clinical Research Manager will be accountable for project management activities, oversight of multiple vendors, and for conducting a global clinical study in compliance with applicable clinical and regulatory standards and in alignment with the business needs. This work is accomplished with minimal oversight, requires frequent contact with internal and external customers, and is critical to the success of the business.

Essential Job Functions:

• Responsible for organizing, communicating, and evaluating team objectives for clinical studies.
• Participates in study design and study preparation activities.
• Development of clinical trial documentation including clinical trial protocol development, case report form (CRF) development, IRB/Ethics submissions.
• Participates or leads the process to evaluate and select potential investigators and sites.
• Conducts or oversees site visits as required (pre-study, initiation, interim, and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct.
• Leads clinical study teams focused on conducting clinical programs consistent with applicable regulations, guidelines, and policies.
• Monitors and tracks clinical trial progress and provides status update reports.
• Manages study budget, payment process, and reconciliation of invoices for all clinical trial vendors including investigative sites when applicable.
• Oversee work and performance of clinical team members, including coaching and supporting any direct reports.
• Analyzes and evaluates clinical data gathered during research.
• Leads, prepares, and reviews project and study-related documents including: informed consent forms, investigational brochures, case report forms, monitoring plans, synopses, protocols and amendments, and other appropriate sections for studies conducted under Investigational Device Exemption (IDE) or 510(k) application.
• Responsible for authoring internal documents, clinical study reports, or clinical evaluation reports.
• Develops and revises annual, interim, and final reports and clinical sections of Pre- or Post-Market Approval submissions.
• Coordinates the design, format, and content of CRFs, study guides, study reference binders, and forms including participating in the EDC and IVRS specification process and UAT.
• Responsible for selection of CRO study staff and coordinating training including documentation.
• Identifies and escalates site, vendor, and study related issues to supervisor, as appropriate.
• Oversees clinical and adverse event data evaluation during the conduct of the study and for completion of clinical study reports.
• Manages training of investigators, site staff, and SWMI clinical staff.
• Oversees quality by maintaining compliance, reviewing device complaints, reviewing audit reports, and implementing corrective actions.
• Other duties as assigned.

Qualifications:

• Bachelor’s Degree in a scientific field of study although we may consider other degree emphasis.
• Medical device experience strongly preferred.
• Minimum 10 years’ experience directly supporting clinical research or relevant experience in medical/scientific area.
• Minimum 1 year in a role directly managing trials and projects, 2-3 years preferred.
• Previous experience directly managing others or equivalent experience.
• Ability to travel 10-20% domestically and internationally.
• Thorough knowledge of Good Clinical Practice (GCP) is required.
• Working knowledge of GCP, FDA, ISO, and other applicable regulations.
• Experience with EDC Data Management Systems.
• Basic understanding of peripheral and coronary artery disease and therapies preferred.
• Knowledge and experience in supporting device pre- and/or post-market clinical studies is required including experience running IDE trials.
• ACRP or SOCRA clinical research certification preferred.
• Able to manage multiple project teams.
• Excellent verbal and written communication skills.
• High attention to detail and accuracy.

The anticipated salary range for this position is US: $115,000 - $197,800 / Bay Area: $141,000 - $227,700.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.